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Home / Company News / The First Chinese Insulin Biologics License Application Submission was Officially Accepted by the US FDA upon the Filing Notification Letter
The First Chinese Insulin Biologics License Application Submission was Officially Accepted by the US FDA upon the Filing Notification Letter


  •  Insulin glargine developed by Gan & Lee Pharmaceuticals (Basalin®) was approved in China in 2005. After nearly 20 years of long-term marketing, it has benefited many diabetes patients and established a good brand reputation.

  •  In 2021, among adults aged 20-79 in the United States, the incidence rate of diabetes (type 1 and 2 combined) was 13.6%, with 32.2 million diabetic patients – ranking fourth highest in the world1. In addition, the annual expenditure in the US related to diabetes for each patient is 11,779.2 USD, second highest in the world1. In 2021, the market size of insulin glargine in the United States was around $2.1 billion USD2. Through a marketing application (Biologics License Application or BLA) in the United States, Gan & Lee Pharmaceuticals will further improve drug accessibility and hopes to deliver value to more patients with diabetes in the US.


Beijing, China/Bridgewater, New Jersey US, February 23rd, 2023—Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee, stock code: 603087.SH), is a leading biopharmaceutical enterprise in China with a history of 25 years, integrating R&D, production and commercialization of human insulin and insulin analogs. Today, the company announced that the submission of Biologics License Application (hereinafter referred to as "BLA") of insulin glargine injection, a proposed biosimilar drug developed by the company for the control of basal blood glucose in diabetic patients, has been accepted for filing by the US Food and Drug Administration (hereinafter referred to as "FDA") and entered the substantive review stage.


Before the BLA submission, two randomized, multicenter, phase 3 studies were completed in the US and EU, comparing the proposed biosimilar Gan & Lee Insulin Glargine Injection to the reference product Lantus®*. The two studies were 26 weeks in duration and enrolled subjects with type 1 (n=576) and type 2 diabetes mellitus (n=567), respectively. In the studies, Gan & Lee Insulin Glargine Injection demonstrated equivalent/comparable immunogenicity, efficacy, and safety to Lantus®.

Dr. Zifei Yuan, CTO of Gan & Lee Pharmaceuticals, said, “It is an exciting milestone that the BLA submission of Gan & Lee Insulin Glargine Injection was accepted for filing by the US FDA. The acceptance has strengthened our confidence in entering the US. We will continue to collaborate with our partner Sandoz to make biosimilar insulin glargine injection available to US diabetic patients.”

Diabetes mellitus

Diabetes mellitus is a chronic health condition that affects how the body turns food into energy. With diabetes, the body doesn’t make enough insulin or can’t use it as well as it should. When there isn’t enough insulin or cells stop responding to insulin, too much glucose stays in the bloodstream. Over time, that can cause serious health problems, such as heart disease, vision loss, and kidney disease3.

Insulin Glargine

Insulin glargine is a long-acting insulin analog, also referred to as basal insulin, which is modified to provide a consistent level of plasma insulin over a long duration as it is injected once a day. Due to its prolonged absorption, there is no pronounced peak concentration in plasma insulin. Thus, it has been associated with better glycemic control and has become an important part of the treatment of diabetes (Standards of Medical Care in Diabetes—2023, ADA, https://doi.org/10.2337/dc23-Srev)


Cooperation with Sandoz AG

In 2018, Gan & Lee Pharmaceuticals signed a commercialization and supply agreement with Sandoz, a division of the international pharmaceutical company Novartis. Under the terms of the agreement, Sandoz has the right to commercialize the three Gan & Lee biosimilars upon approval in specific regions, including the United States, Europe, and other key territories. Gan & Lee is responsible for development (incl. clinical research) and supply.

About Gan & Lee

Gan & Lee Pharmaceuticals has developed the first Chinese domestic biosynthetic human insulin. Currently, we have five recombinant insulin analogs commercialized in China including long-acting glargine injection (Basalin®), fast-acting lispro injection (Prandilin), fast-acting aspart injection (Rapilin®), mixed protamine zinc lispro injection (25R) (Prandilin25), aspart 30 injection (Rapilin®30), and one human insulin injection - mixed protamine human insulin injection (30R) (Similin®30). We have two approved medical devices in China, namely reusable insulin injection pen (GanleePen), and disposable pen needle (GanleeFine®).


In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance our goal of becoming a world-class pharmaceutical company, we will also take an active part in developing new chemical entities, and work on the treatment of cardiovascular diseases, metabolic diseases, cancer, and other therapeutics. 

*Lantus® is a registered trademark of Sanofi S.A.


1.      IDF Diabetes Atlas 10th edition 2021. Available at: https://diabetesatlas.org/atlas/tenth-edition/

2.      Evaluate Pharma

3.      Centers for Disease Control and Prevention. Diabetes: what is diabetes. Available at: https://www.cdc.gov/diabetes/basics/diabetes.html


This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “positive opinion,” “recommendation,” “proposed,” “potential,” “can,” “will,” “believe,” “committed,” “investigational,” “portfolio,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labelling for the investigational or approved biosimilar products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements.


Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such biosimilar products will be approved for all indications included in the reference product’s label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Gan & Lee from selling its products; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors. Gan & Lee is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.


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